The Respiratory Protection Effectiveness Clinical Trial (ResPECT)

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Despite widespread use of respiratory protective equipment in the U.S. healthcare workplace, there is very little clinical evidence that respirators prevent healthcare personnel (HCP) from airborne infectious diseases. Scientific investigation of this issue has been quite complicated, primarily because the use of respirators has become "the standard of care" for protection against airborne diseases in some instances, even without sufficient evidence to support their use. The key question remains: How well do respirators prevent airborne infectious diseases? The answer to this important question has important medical, public health, political and economic implications.

To determine and analyze the magnitude of the change, if any, in incidence of laboratory confirmed influenza in healthcare practitioners wearing N95 respirators (2009 Centers for Disease Control and Prevention (CDC) guidelines) compared to medical masks (2007 guidelines).

To determine and analyze the magnitude of the change, if any, in incidence of acute respiratory illness, influenza-like illness, and lab-confirmed respiratory illness in HCPs wearing N95 respirators compared to medical masks.

To examine the relationship between incidence and possible risk factors, including compliance, attitudes and opinions of HCPs and workplace exposures.

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Ages Eligible for Study:

18 Years to 100 Years (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Clinical site leadership has agreed to have one or more staff participate in the trial

Subject meets the definition of "healthcare personnel"

Subject able to read and sign informed consent

Subject agrees to all requirements of the protocol, including fit testing and diary keeping

Subject's age is 18 or greater

Subject passes fit testing for one of the study supplied respirator models and agrees to use that model for the entire intervention period of the study (if in respirator arm).

Exclusion Criteria:

Subject self-identified as having severe heart, lung, neurological or other systemic disease that one or more Investigator believes could preclude safe participation

Known to not tolerate wearing respiratory protective equipment for any period

Facial hair, or other issue such as facial adornments, precluding respirator OSHA-compliant fit testing or proper mask fit during the study period

Advised by Occupational Health (or other qualified clinician) to not wear the same or similar respirator or medical mask models used in this study

In the opinion of the Investigator, may not be able to reasonably participate in the trial for any reason

Self-identified as in, or will be in the third trimester of pregnancy, during the study period.